三生國健(688336.SH)上半年研發投入佔比54% 未來5年預計遞交4到5個創新抗體藥上市申請
格隆匯8月17日丨中國抗體藥領軍企業三生國健(688336.SH)公佈2020年上半年業績：在新冠疫情的考驗下，公司迎難而上，在研發以及業務運營方面取得重大進展，其中研發投入1.9億元，較去年同期增加42.8%，佔營業收入的比重達到54.01%。未來5年內，公司預計將陸續有4至5個創新抗體藥產品提交上市申請。
2020年上半年，受到市場競爭加劇和新冠疫情的影響，公司產品銷售受到衝擊。上半年公司實現營業收入3.51億元，較上年同期同比減少32.1%。其中核心產品益賽普銷售收入3.31億元，同比減少34%。
不過，隨着境內新冠病毒疫情的日益緩解，益賽普銷售收入在二季度呈現逐步恢復趨勢。益賽普已在國內上市15年，療效與安全性相比同類TNF-a抑制劑產品得到更加廣泛的臨牀驗證與認可。此外預充式益賽普水針劑301S已向國家藥監局申請生產批件並獲受理，預計2021年上市銷售，新劑型將有助於提高患者用藥依從性。
2020年6月19日，公司自主研發的注射用伊尼妥單抗(商品名：賽普汀®)正式獲得國家藥品監督管理局批准，首個適應症為和化療聯合用於治療HER2陽性的轉移性乳腺癌。獲批12天即在全國多省市開出首張處方。
2020上半年公司研發投入合計1.9億元，較去年同期增加42.8%，佔營業收入的比重達到54.01%。公司目前擁有17個處於不同開發階段、涵蓋腫瘤、自身免疫性及眼科等疾病領域的在研抗體藥物(包括9個處於臨牀及新藥註冊階段的在研藥物、8個處於臨牀前階段的在研藥物)，其中大部分在研藥物為治療用生物製品1類或單克隆抗體，部分在研藥物為中美雙報。公司在2020上半年新增兩項臨牀試驗批准，其中611抗IL4Rα抗體獲得FDA臨牀試驗批准並獲得NMPA受理，用於治療特應性皮炎；610抗IL5抗體獲得NMPA臨牀試驗批准，用於治療重度嗜酸性粒細胞性哮喘。
此外，公司多項臨牀試驗進展順利。用於治療多種癌症的抗PD1抗體609A美國Ⅰ期臨牀試驗完成患者入組並開始中國患者入組；用於中重度斑塊狀銀屑病的抗IL-17A抗體608已完成Ⅰ期臨牀試驗者入組並正計劃進行Ⅱ期臨牀試驗；抗CD20單抗304R已完成與利妥昔單抗的Ⅰ期頭對頭對比臨牀試驗；抗VEGF抗體601A治療AMD的Ⅰ期臨牀患者入組完成，治療DME的Ⅰ期臨牀試驗正在按計劃入組。
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